Pfizer's PCSK9 drug notches two Phase 3 wins

Bococizumab would be the third PCSK9 drug to hit U.S. markets, but Pfizer hopes to distinguish it with stronger clinical data. 

By Nicole Gray • June 30, 2016

Major trade group slams 'misleading' analysis of drug prices

In an op-ed Wednesday, the president of BIO pushed back on a recent Bloomberg report on rising drug prices, calling it "conjecture." 

By Ned Pagliarulo • June 30, 2016

Explore the Trendline➔

Commercialization

New drugs for obesity and Alzheimer’s look set to become blockbusters, reshaping pharma marketing strategies just as many current top-sellers near looming patent cliffs.

By BioPharma Dive staff

In narrow vote, FDA panel supports heart benefit claim for Lilly diabetes drug

Allowing Boehringer and Lilly to claim Jardiance cuts the risk of cardiac death is expected to significantly boost the drug's market potential. 

By Ned Pagliarulo • June 29, 2016

What does it take to succeed as a New York biotech startup?

Although biotech has been slow to take off in New York, venture activity in the city may be accelerating. BioPharma Dive spoke with the CEO of Rgenix about why he plans to stay.  

By Nicole Gray • June 29, 2016

Harvard Pilgrim inks pay-for-performance deals with Novartis, Eli Lilly

Outcomes-based pricing has become more common as insurers seek to limit rising prescription drug costs. 

By Ned Pagliarulo • June 28, 2016

Gilead wins FDA nod for pan-genotypic Hep C drug

In an unusual move, Gilead priced Epclusa below the cost of existing drugs Harvoni and Sovaldi, at just under $75,000 for a 12-week course of treatment. 

By Ned Pagliarulo • June 28, 2016

Teva seals deal to market copy of AstraZeneca diabetes drug

Under settlement terms, the Israeli drugmaker will be able to sell generic versions of AstraZeneca's Byetta next year. 

By Ned Pagliarulo • June 24, 2016

Opko wins approval for kidney drug after manufacturing snag

The FDA had turned down Opko's original application due to manufacturing issues at third-party contractor Catalent. 

By Nicole Gray • June 23, 2016

Russian biosims company accuses Roche of undercutting its business

Filing suit in a New York federal court, Biocad claimed Roche tried to block it from entering the U.S. market with biosimilar versions of three Roche cancer drugs.

By Nicole Gray • June 23, 2016

AstraZeneca writes off $80 million after US authorities say nasal flu vaccine ineffective

An advisory panel at the Centers for Disease Control and Prevention recommended against using AstraZeneca's FluMist nasal spray for the upcoming flu season. 

By Ned Pagliarulo • June 23, 2016

Doctors who ate on pharma's dime prescribed drugs more often, study finds

Higher rates of prescribing were seen even though the average meal cost less than $20. 

By Nicole Gray • June 22, 2016

Supreme Court asks for DOJ input on biosimilar case, delaying decision

Novartis' generics unit Sandoz is locked in a legal battle with Amgen over when biosimilars companies can launch copies of branded drugs. 

By Nicole Gray • June 22, 2016

Could label update for diabetes med Jardiance boost drug class?

A new forecast predicts the so-called SGLT-2 diabetes drugs, headlined by Jardiance, could become the third best-selling class of drugs by 2022. 

By Nicole Gray • June 22, 2016

Austin biotech Savara adds two lung drugs in deal for Serendex

Savara raised $20 million in March to advance its lead drug, an inhaled antibiotic, into Phase 3 testing. 

By Nicole Gray • June 22, 2016

Philips ad for lung device wins top honors at Cannes

Several big pharma companies, such as Pfizer and Teva, also took awards for their ads at the international marketing competition. 

By Nicole Gray • June 21, 2016

Clinton racks up donations from pharma industry

Although individual donations from pharma made up a small share of Clinton's overall fundraising, her total far exceeded amounts raised by Donald Trump or Bernie Sanders. 

By Nicole Gray • June 20, 2016

NIH turns down request to override cancer drug patent

Consumer groups had argued the $129,000 price tag for Xtandi limits patient access, justifying intervention by the government under a little-used law.

By Ned Pagliarulo • June 20, 2016

Doubling down on biosimilars, Novartis plans five launches by 2020

The Swiss giant aims to introduce biosimilar copies of blockbuster biologic drugs, such as AbbVie's Humira and Roche's Rituxan, by the end of the decade. 

By Ned Pagliarulo • June 20, 2016

Why Novartis' new heart med could reverse slow start

BioPharma Dive spoke to Clyde Yancy, Chief of Cardiology at Northwestern University, about the new clinical practice guidelines recommending Entresto.

By Nicole Gray • June 17, 2016

Payer interest grows in outcomes-based drug deals: report

Health plans were particularly interested in pay-for-performance deals for hepatitis C and oncology therapies, according to a survey conducted by Avalere 

By Nicole Gray • June 17, 2016

Roche's combo melanoma treatment turned down by UK cost watchdog

While the combination of Cotellic and Zelboraf is approved in Europe, the U.K. agency deemed the drugs not cost-effective. 

By Nicole Gray • June 17, 2016

Lilly and Boehringer's Jardiance sets new bar, shows kidney benefit

Other drugmakers have rushed to match the drug's previously proven cardiovascular benefit, but new data shows it can help slow the progression of kidney disease. 

By Nicole Gray • June 15, 2016

Success rate for clinical trials climbed in recent years: study

Research published in Nature showed an 11.6% likelihood of drugs moving from Phase 1 to launch, higher than another study recently conducted by BIO. 

By Nicole Gray • June 15, 2016

FDA wants to suspend more than 4,000 illegal Rx sites

U.S. consumers have purchased unapproved medications from international sellers to treat depression, narcolepsy, glaucoma and other medical conditions. 

By Nicole Gray • June 10, 2016

Alexandria Center for Life Sciences offers $25M in seed funding for small biotechs

Alexandria LaunchLabs is accepting applications for biotech start-ups looking for seed funding and space in New York. 

By Nicole Gray • June 9, 2016